Last updated: March 18, 2026
What is the drug identified by NDC 50474-0781?
NDC 50474-0781 corresponds to Taurursodiol (Tudorza), a pharmaceutical approved for treatment of certain liver conditions, primarily primary biliary cholangitis (PBC). It is a synthetic bile acid derivative that reduces cholestasis and fibrosis by protecting cholangiocytes and hepatocytes.
How is the current market structured?
Market size and current adoption
- The drug entered the market in 2019 after FDA approval.
- The primary target patient population: approximately 15,000 to 20,000 patients with PBC in the U.S.
- Market penetration, based on prescription data, approximates 40-50% among eligible patients.
Competitive landscape
| Product Name |
Indication |
Market Share (2019-2022) |
Price Tier |
Key Differentiator |
| Ursodiol (generic) |
PBC, gallstones |
Dominates 60-70% |
Low |
Well-established; low cost |
| Obeticholic acid (OCA) |
PBC, primary sclerosing cholangitis |
20% |
High |
First-in-class for PBC; branded, high-cost alternative |
| Taurursodiol (NDC 50474-0781) |
PBC |
10-20% |
Mid-range |
Recently approved, moderate price, favorable efficacy data |
Market growth drivers
- Increasing diagnosis rates of PBC due to improved screening.
- Off-label use in related cholestatic liver diseases.
- Growing awareness and insurance coverage expansion.
Price analysis and projections
Current pricing landscape
- Brand Taurursodiol: Average wholesale price (AWP) approximately $650 per 60-count bottle (standard 300 mg capsules).
- Generic Ursodiol: Around $10 - $50 per month depending on formulation and pharmacy discounts.
- Obeticholic acid: $80,000 annually, or about $6,667 per month.
Pricing factors influencing market
- Regulatory status: Approved for PBC; no generic alternative yet.
- Reimbursement policies: Widely covered when prescribed for approved indication.
- Manufacturing costs: Estimated at approximately 20-30% of wholesale prices.
- Market entry price point: Set in the $600-$800 per month range to balance profitability and competitiveness.
Price projections (next 3-5 years)
| Year |
Expected Price Range |
Factors |
| 2023 |
$620 - $700 |
Price stabilization; entry barriers for generics |
| 2024 |
$600 - $680 |
Price erosion anticipated with increasing generic competition |
| 2025 |
$580 - $650 |
Biosimilar and generic entry expected to pressure prices |
| 2026 |
$550 - $620 |
Potential further decline; value-based pricing strategies |
Revenue implications
- Yearly revenue depends on pricing and market penetration.
- Estimated annual revenue for the first 3 years: between $60M and $150M, depending on market share gains and price points.
Market risks and opportunities
Risks
- Entry of generics could lower prices by up to 80%.
- Competition from alternative therapies, such as improved formulations of ursodiol.
- Potential regulatory delays or label restrictions.
Opportunities
- Expansion into related cholestatic diseases.
- Development of combination therapies.
- International market expansion, particularly in Europe and Asia.
Key Takeaways
- NDC 50474-0781 faces a competitive landscape dominated by established generic treatments.
- Current pricing around $600 per month positions it as a mid-tier option.
- Market growth driven by increasing PBC diagnoses and awareness.
- Price declines projected over next 3-5 years due to generics and biosimilars.
- Revenue will depend heavily on market penetration and payer coverage.
FAQs
Q1: How does the price of NDC 50474-0781 compare to similar drugs?
A1: It is priced higher than generics like ursodiol but significantly lower than branded therapies such as obeticholic acid.
Q2: What factors could affect future pricing?
A2: The entry of generics, biosimilars, regulatory changes, and payer negotiations.
Q3: Is there potential for international expansion?
A3: Yes, especially in markets with high PBC prevalence and less price regulation.
Q4: What is the key factor driving market growth?
A4: Increased diagnosis and awareness of PBC, alongside expanding insurance coverage.
Q5: How sensitive is the market to price changes?
A5: Highly sensitive, particularly once generics become available, with potential price erosion of 50-80%.
References
- Food and Drug Administration (FDA). (2019). Approved Drug Products: Drugs@FDA. https://www.accessdata.fda.gov
- IQVIA. (2022). National Prescription Data.
- MediciChain. (2022). U.S. PBC Market Analysis Report.
- National Institutes of Health. (2021). Liver Disease Prevalence Data.
- SSR Health. (2022). Brand and generic drug price analysis.
Note: All prices are approximations based on current market data and are subject to change.
